Ramai Daryl, DeLuca Matthew, Facciorusso Antonio, Ofosu Andrew, Girotra Mohit, Tabibian James H, Rodrigues-Pinto Eduardo, Adler Douglas G, Barakat Monique T
Division of Gastroenterology and Hepatology, University of Utah, Salt Lake City, UT.
Section of Gastroenterology, Department of Medical Sciences, University of Foggia, Foggia, Italy.
J Clin Gastroenterol. 2022 Oct 1;56(9):784-786. doi: 10.1097/MCG.0000000000001632. Epub 2021 Dec 15.
Colonic stents are indicated for preoperative and palliative decompression of large bowel obstruction. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with colonic stents.
We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to December 2020.
During the study period, 691 device issues and 742 patient complications were identified. The number of adverse events reported to the FDA mildly increased from 6.40% in 2011 to 7.4% in 2020. Most device complications were due to a positioning problem (n=201, 29%), followed by device break (n=60, 8.6%), delamination (n=41, 6.3%), and migration or expulsion device (n=38, 5.55%). A number of reports described an unclassified adverse event without specifying device or operator problem (n=141, 20.3%). The most reported patient adverse events were perforation (n=150, 20.1%), death (n=47, 6.3%), abdominal pain/discomfort (n=27, 3.6%), and peritonitis (n=24, 3.2%).
Findings from the MAUDE database highlight rare but important patient and device complications which endoscopists and referring providers should be aware of before consideration for colonic stent placement.
结肠支架适用于大肠梗阻的术前和姑息性减压。我们旨在研究美国食品药品监督管理局（FDA）批准后与结肠支架相关的结果。
我们分析了2011年1月至2020年12月期间FDA制造商和用户设施设备经验（MAUDE）数据库的上市后监测数据。
在研究期间，共识别出691起设备问题和742例患者并发症。向FDA报告的不良事件数量从2011年的6.40%略有增加到2020年的7.4%。大多数设备并发症是由于定位问题（n = 201，29%），其次是设备断裂（n = 60，8.6%）、分层（n = 41，6.3%）和移植物迁移或排出（n = 38，5.55%）。许多报告描述了未分类的不良事件，但未具体说明设备或操作者问题（n = 141，20.3%）。报告最多的患者不良事件是穿孔（n = 150，20.1%）、死亡（n = 47，6.3%）、腹痛/不适（n = 27，3.6%）和腹膜炎（n = 24，3.2%）。
MAUDE数据库的研究结果突出了罕见但重要的患者和设备并发症，内镜医师和转诊提供者在考虑放置结肠支架之前应予以关注。
